San Diego, CA, United States
Quidel Corporation recalls
10 recalls recorded since 2018, most recently on 6 April 2026. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls10
Ongoing (FDA)5
Terminated or completed5
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 6 April 2026
- Reason
- Product has the potential for false positive results
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2169-2026
- QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Ongoing Class II Medical devices
- Recall started
- 17 June 2025
- Reason
- Dipstick strep A test has potential for false positive results.
- Distribution
- Worldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC, FL, TN, MS, MN, IL, MO, KS, LA, TX, CO, ID, CA, AK, NY, PA and the countries of Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2545-2025
- QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Ongoing Class II Medical devices
- Recall started
- 5 March 2024
- Reason
- There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
- Distribution
- US: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NH NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI WV OUS: United Arab Emirates, Belgium, Canada, Chile, China, Germany, Spain, United Kingdom, Ireland, Italy, South Korea, Lithuania, Qatar
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1637-2024, Z-1636-2024
- QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
- QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Ongoing Class II Medical devices
- Recall started
- 3 January 2024
- Reason
- One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life.
- Distribution
- US Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1086-2024
- The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for t
Ongoing Class II Medical devices
- Recall started
- 1 February 2023
- Reason
- Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
- Distribution
- not yet available
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1308-2023
- MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
Terminated Class II Medical devices
- Recall started
- 13 August 2021
- Terminated
- 2 November 2023
- Reason
- Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target amplification occurs prior to a cycle-threshold (Ct) value of 5 when using the Thermo Fisher QuantStudio 7 Pro, the Applied Biosystems 7500 Fast Dx, the Applied Biosystems 7500, the Bio-Rad CFX96 Touch", the Roche LightCycler LC 480 II/ cobas z 480, or the Qiagen Rotor-Gene¿ MDx.
- Distribution
- Worldwide distribution - US Nationwide distribution including Puerto Rico and the countries of Canada, Panama, Virgin Islands, Germany, Honduras.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2477-2021
- Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS),
Terminated Class I Medical devices
- Recall started
- 27 April 2021
- Terminated
- 8 September 2022
- Reason
- In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, CT, DC, FL, ID, IN, MA, MI, MO, NM, NY, OH, SC, TN, TX, WA and the countries of Canada, Saudi Arabia, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1928-2021
- Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Terminated Class II Medical devices
- Recall started
- 25 September 2020
- Terminated
- 18 September 2024
- Reason
- Due to false positive results.
- Distribution
- U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0428-2021
- QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Terminated Class II Medical devices
- Recall started
- 17 September 2020
- Terminated
- 9 August 2022
- Reason
- Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.
- Distribution
- U.S. Nationwide Distribution: NY, KS, TX, AL, FL, MN, CA, IL, MA, MS, PA, GA, NH, MO, VA, MI, OR, WV, OK, NV, CT, TN, MD, LA, AR, HI, NJ, KY, VT, IA, RI, NM, OH, IN, AK, SC, NC, AZ, SD, NE, WI, and.CO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0124-2021
- Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nuc
Terminated Class II Medical devices
- Recall started
- 15 December 2017
- Terminated
- 21 October 2019
- Reason
- The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported.
- Distribution
- US Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1183-2018
- Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.